Neoadjuvant Immunotherapy Plus Chemotherapy in Borrmann Type 4 and Large Type 3 Gastric Cancer

NCT ID: NCT06451211

Last Updated: 2024-06-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-17
• Study Completion Date: 2027-11-30

Brief Summary

The aim of this study is to test the efficacy and safety of immunotherapy plus chemotherapy on people with a relatively rare type of gastric cancer. Participants will take the anti-PD-1 inhibitor (Tislelizumab) and platinum-based chemotherapy (oxaliplatin + capecitabine or oxaliplatin + S-1) in a 3-week cycle, followed by a radical operation after 6 cycles.

Conditions

Stomach Neoplasms; Gastric Cancer; Linitis Plastica of Stomach

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tislelizumab + SOX/XELOX

Patients with borrmann type 4 or large type 3 (over 8 cm) gastric cancer, who are deemed to be surgically resectable, are treated with neoadjuvant Tislelizumab (200 mg) and oxaliplatin (150 mg) intravenously on day 1 plus capecitabine (2500 mg) or S-1 (40 mg) orally on day 1-14 in each 21-day cycle. Radical gastrectomy will be performed after 6 cycles, followed by adjuvant chemotherapy (capecitabine or S-1).

Group Type: EXPERIMENTAL

Tislelizumab

Intervention Type: DRUG

Tislelizumab 200 mg will be administered systemically on day 1 of each cycle in all participants

Oxaliplatin

Intervention Type: DRUG

Oxaliplatin 150 mg will be administered systemically on day 1 of each cycle in all participants

S-1

Intervention Type: DRUG

S-1 40 mg will be administered orally on day 1-14 of each cycle in all participants

Capecitabine

Intervention Type: DRUG

Capecitabine 2500 mg will be administered orally on day 1-14 of each cycle in all participants

Interventions

Tislelizumab

Tislelizumab 200 mg will be administered systemically on day 1 of each cycle in all participants

Intervention Type: DRUG

Oxaliplatin

Oxaliplatin 150 mg will be administered systemically on day 1 of each cycle in all participants

Intervention Type: DRUG

S-1

S-1 40 mg will be administered orally on day 1-14 of each cycle in all participants

Intervention Type: DRUG

Capecitabine

Capecitabine 2500 mg will be administered orally on day 1-14 of each cycle in all participants

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed gastric adenocarcinoma,cT1-2N+M0 or cT3-4NanyM0;
• Males or females, aged 18-70 years;
• Gastroscopy and abdominal computed tomography (CT) scan-confirmed typical scirrhous gastric cancer (borrmann type 4) or large type 3 (over 8 cm);
• No peritoneal metastasis confirmed by laparoscopic exploration and with cytological examination of peritoneal washing of the Douglas pouch;
• ECOG performance status 0 or 1;
• Sufficient organ function:

• white blood cell count > 4*10^9/L, neutrophil cell count > 1.5*10^9/L, hemoglobin > 90 g/L, platelet count > 100*10^9 /L
• Serum bilirubin ≤ 1.5×upper limit of normal (ULN), AST, ALT ≤ 2.5×ULN
• Creatinine ≤ 1.5 ×ULN or serum clearance > 60 ml/min
• INR and aPTT ≤ 1.5 × ULN, only for subjects not receiving anticoagulant therapy;Subjects undergoing coagulation therapy should use a stable dose
• No prior anti-tumor therapy;
• Have signed informed consent before the beginning of treatment.

Exclusion Criteria

• History of another malignancy within the last five years;
• Previous cytotoxic chemotherapy, radiotherapy or immunotherapy
• Unable to take drugs orally
• Allergic to to any drug of the study regimen;
• Women who are pregnant or breastfeeding or may be pregnant

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Haibo Qiu

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Haibo Qiu, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Haibo Qiu, MD, Ph.D

Role: CONTACT

qiuhb@sysucc.org.cn

020-87343910

Chao Ding, MD, Ph.D

Role: CONTACT

dingchao@sysucc.org.cn

020-87343123

Facility Contacts

Haibo Qiu

Role: primary

qiuhb@sysucc.org.cn

020-87343910

Other Identifiers

2022-FXY-203

Identifier Type: -

Identifier Source: org_study_id